Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery

NCT ID: NCT02943980

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-03
• Study Completion Date: 2019-02-15

Brief Summary

A randomized controlled prospective study of laryngoscopy and evaluation of the Intraoperative nerve monitoring during thyroid surgery comparing direct laryngoscopy and the C-MAC videolaryngoscope.

Detailed Description

Intraoperative nerve monitoring (IONM) is used in addition to the visual the nerve in thyroid surgery. Here, the IONM can be done by placing electrodes on an endotracheal tube. In order to guarantee a sufficient signal quality of the IONM, the electrode must be adequately positioned on the glottis. The present study pursued the question of whether the conventional direct laryngoscopy compared with video laryngoscopy allows a visually adequate tube placement.

Conditions

Thyroid; Airway Morbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CMAC Videolaryngoscope

tracheal intubation using CMAC

Group Type: EXPERIMENTAL

CMAC Videolaryngoscope

Intervention Type: DEVICE

In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC

Macintosh laryngoscope

tracheal intubation using Macintosh laryngoscope

Group Type: EXPERIMENTAL

Macintosh Laryngoscope

Intervention Type: DEVICE

In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope

Interventions

CMAC Videolaryngoscope

In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC

Intervention Type: DEVICE

Macintosh Laryngoscope

In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 Years No concurrent participation in another study
• capacity to consent
• Present written informed consent of the research participant
• Elective surgery under general anesthesia

Exclusion Criteria

• Age <18 years
• Existing pregnancy
• Lack of consent
• inability to consent
• emergency patients
• Emergency situations in the context of a Difficult Airway Management
• ASA classification 4
• situations where the possibility of accumulated gastric contents
• Participation in another study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Marc Kriege, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc Kriege, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center

Locations

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

Other Identifiers

JGU

Identifier Type: -

Identifier Source: org_study_id